In a 6-year open-label study
- Only 0.16% of patients discontinued due to abnormal ejaculation (FLOMAX 0.4 mg)1 Learn more about this trial
In a randomized, double-blind, placebo-controlled multicenter study of 625 patients comparing FLOMAX 0.4 mg vs alfuzosin 10 mg and 15 mg:
- The incidence of ejaculatory failure was 1.3% for both FLOMAX 0.4 mg and alfuzosin 10 mg2 Learn more about this trial
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Important Safety Information
Flomax® (tamsulosin HCl) capsules are indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension.
FLOMAX is contraindicated in patients who are hypersensitive to tamsulosin HCl or any of its components.
As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. When beginning treatment, or increasing the dose of FLOMAX, patients should be cautioned to avoid driving or performing hazardous tasks where injury could result should syncope occur.
FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g.,ketoconazole).
Rarely (probably less than 1 in 50,000 patients) FLOMAX, like other alpha-1 antagonists, has been associated with priapism. Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.
Carcinoma of the prostate and BPH cause many of the same symptoms. Patients should be evaluated prior to the start of FLOMAX capsules therapy to rule out the presence of carcinoma of the prostate.
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers, including FLOMAX capsules. Patients should be advised that if they are considering cataract surgery, to tell their ophthalmologist that they have taken FLOMAX capsules.
In patients with sulfa allergy, allergic reaction to FLOMAX capsules has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted.
FLOMAX capsules should NOT be used in combination with other alpha-adrenergic blocking agents. Caution is advised when alpha-adrenergic blocking agents, including FLOMAX, are co-administered with PDE 5 inhibitors, as this can potentially cause symptomatic hypotension.
FLOMAX capsules (particularly at a dose higher than 0.4 mg) should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers.
Caution should be exercised with concomitant administration of warfarin and FLOMAX and should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg.
The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
Before prescribing FLOMAX, please see the Full Prescribing Information.
* In 2 European, 12-week, randomized, placebo-controlled clinical trials.
† US placebo-controlled registration trials 92-03A and 93-01.
1. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
2. Center for Drug Evaluation and Research. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/foi/nda/2003/21-287_uroxatral_medr_p2.pdf. Accessed September 16, 2005.
3. Höfner K, Claes H, De Reijke TM, et al, for the European Tamsulosin Study Group. Tamsulosin 0.4 mg once daily: effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol. 1999;36:335-341.
